NCT03704168

Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders

Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dean Nakamoto · Academic / Other
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. Secondary Objective: To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. Duration: Estimation for Recruitment: 12 months Estimation for Procedure/Trial: 1 visit with an overnight observation Estimation for Subject Follow Up: 7 days, 14 days, 28 days, 90 days, and 180 days, post ablation, with ultrasound of the bilateral submandibular glands at 28 days and 180 days post ablation Total Expected Duration for Clinical Trial: 2 years

Conditions

• Sialorrhea
• Neurologic Disorder

Interventions

Type	Name	Description
DEVICE	CRYOABLATION	The SeedNet® System induces freezing and thawing at the tip of the needle. These freezing and thawing processes are based on the Joule-Thomson effect. The unique technology of the SeedNet® System provides extremely rapid freeze and thaw operations. The system's software controls the flow of gases from the gas sources, through the manifold, to the needle and probe tips. The system can immediately switch from the freezing process to the thawing process, after which the needle can be released. This device is an FDA-cleared medical device. This IDE application is to allow for use of the commercially available device in a new clinical indication, namely cryoablation of the submandibular glands.

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2018-10-12
• Last updated: 2021-11-29